Efficacy of B12 Fortified Nutrient Bar and Yogurt in Improving Plasma B12 Concentrations-Results From 2 Double-Blind Randomized Placebo Controlled Trials

Abstract

Background: Dietary vitamin B₁₂ (B₁₂) deficiency is common in Indians. Long-term compliance to tablet supplementation is poor in asymptomatic individuals.

Objective: To study efficacy of B₁₂ fortified nutrient bar and yogurt in improving plasma B₁₂ concentrations in children and adults.

Methods: Two double-blind, placebo-controlled directly observed therapy randomized controlled trials were conducted for 120 days: (1) Healthy children (10-13 years) were fed nutrient bar fortified with B₁₂ (2 μg), multiple micronutrients B₁₂ (1.8 μg) or placebo. (2) Healthy adults (18-50 years) were fed yogurt fortified with B₁₂ (2 μg) or Propionibacterium (1 × 10⁸ cfu/g) or placebo. B₁₂, folate, homocysteine, and hemoglobin concentrations were measured before and post intervention.

Results: We randomized 164 children and 118 adults; adherence was 96% and 82%, respectively. In children, B₁₂ fortified bars increased B₁₂ concentrations significantly above baseline (B₁₂ alone +91 pmol/L, B₁₂+ multiple micronutrients +82 pmol/L) compared to placebo. In adults, B₁₂ fortified yogurt increased B₁₂ significantly (+38 pmol/L) but Propionibacterium and placebo did not. In both trials, homocysteine fell significantly with B₁₂ supplementation. Rise of B₁₂ and fall of homocysteine were influenced by dose of B₁₂ and folic acid. There was no significant difference in change of anthropometry and hemoglobin between groups.

Conclusions: B₁₂ fortified foods are effective in improving B₁₂ status in Indian children and adults. They could be used to improve B₁₂ status in the national programs for children, adolescents, and women of reproductive age. They could also be used as over-the-counter products.

Keywords: B12 fortified foods; India; nutrient bar and yogurt; randomized controlled trial; vitamin B12 deficiency.